Subject reported outcomes on satisfaction, efficacy and safety with Luxerm® in the field-directed treatment of thin or non-hyperkeratotic and non-pigmented Actinic Keratosis of the face or the scalp

Galderma R&D0 sites50 target enrollmentMarch 13, 2017

ConditionsThin or non-hyperkeratotic and non-pigmented Actinic Keratosis on the face and scalp MedDRA version: 19.1Level: HLTClassification code 10020648Term: HyperkeratosesSystem Organ Class: 100000004858 Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

DrugsLuxerm® 160mg/g creme

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Thin or non-hyperkeratotic and non-pigmented Actinic Keratosis on the face and scalp
Sponsor: Galderma R&D
Enrollment: 50
Status: Active, not recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 13, 2017

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Galderma R&D

Eligibility Criteria

Inclusion Criteria

•1\-Male or female age above 18 years old.
•2\-Subject with at least 5 clinically confirmed thin or non\-hyperkeratotic and non\-pigmented actinic keratoses in an anatomical area on the face (e.g., forehead or cheek or chin) excluding nose, eyelids, lips and mucosa, or balding scalp, at baseline visit.
•3\-Subject or caregiver capable of performing the skin preparation and Luxerm? treatment application as per the investigator instructions.
•4\-Female subject of childbearing potential must have a negative UPT at baseline (UPT should have a sensitivity of 25 IU/L or less) and agree to be strictly abstinent or use a highly effective method of birth control during the study (i.e. progestogen\-only oral hormonal contraception; male or female condom; cap, diaphragm or sponge with spermicide; bilateral tubal ligation; combined (estrogen and progestogen\-containing) oral hormonal contraception, or injectable or implants hormonal contraception (at a stable dose for at least 1 month prior to baseline); intra\-uterine devices inserted at least 1 month prior to baseline; vasectomized partner for at least 3 months prior to baseline).
•5\-Female subject of non\-childbearing potential, e.g.: post\-menopausal (absence of menstrual bleeding for 1 year without any other medical reason), hysterectomy or bilateral ovariectomy.
•6\-Subject has read and signed the approved informed consent form (ICF) prior to any participation in the study.
•7\-Subject has read and signed a Photograph Release Consent Form if he/she is willing to be photographed.
•8\-Subject (or caregiver) willing and able to comply with all of the time commitments and procedural requirements of the clinical trial protocol.
•Are the trial subjects under 18? no
•Number of subjects for this age range:

Exclusion Criteria

•1\-Subject with a clinical diagnosis of a skin disease other than AK (including non\-melanoma skin cancer) on the target anatomical area.
•2\-Subject with severe AK (thick, hyperkeratotic AK) per anatomical area (face or scalp).
•3\-Subject with clinical diagnosis of other skin disease on the target anatomical area.
•4\-Subject with pigmented AK on the target anatomical area.
•5\-Subject with melanoma at any location.
•6\-Immunocompromised subject or requiring immunosuppressive therapies.
•7\-Subject with porphyria; photosensitivity\- related disorders, active infectious disease.
•8\-Subject with known or suspected hypersensitivity to the active substance or to any excipients of Luxerm® (see Summary of Product Characteristics).
•9\-Female subject who is pregnant, nursing or planning a pregnancy during the study.
•10\-Subject who has used any of the following topical preparations on the area to be treated: keratolytics including urea (greater than 5%), alpha hydroxyacids \[e.g. glycolic acid, lactic acid, etc. greater than 5%], salicylic acid (greater than 2%) within 2 days of initiation of treatment.